APPLICATION
ANDA065314
TYPE
ANDA
ORIGINAL APPROVAL
2006-11-27
LATEST ACTION
2026-03-03
ROUTE
INTRAVENOUS, INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMPICILLIN AND SULBACTAMPrescription
AMPICILLIN SODIUM EQ 10GM BASE/VIAL, SULBACTAM SODIUM EQ 5GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2026-03-03Labeling · Supplement 14 · standardAP
2026-03-03Labeling · Supplement 20 · standardAP
2026-03-03Labeling · Supplement 11 · standardAP
2026-03-03Labeling · Supplement 18 · standardAP
2006-11-27OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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